{"analyses":[{"groupDescription":"The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"stratified by age group (\\< 60 years, \\>= 60 years) and region (Europe, North-America, Asia)","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.454","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.758","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.587","statisticalComment":"stratified by age group and region","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"278","upperLimit":"393","value":"329"},{"groupId":"OG001","lowerLimit":"160","upperLimit":"238","value":"175"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"210"}],"units":"Participants"}],"description":"PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.","reportingStatus":"POSTED","timeFrame":"Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years","title":"Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation","type":"PRIMARY","unitOfMeasure":"Days"}